A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.
Bipolar Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Risperidal CONSTA, Bipolar disorder, mood episodes, Safety and efficacy, adjuvant therapy
Eligibility Criteria
Inclusion Criteria: Must provide informed consent Must agree to receive regular injections Must have current diagnosis of bipolar disorder I or II Must have at least four episodes of mood disorder in the last year that required psychiatric intervention Exclusion Criteria: Female who is or may be pregnant or breastfeeding, who is not at least 1 year postmenopausal, or is not using reliable and adequate birth control Psychiatric diagnosis is due directly to effects of a substance or general medical condition Substance dependence Received treatment with a long-acting injectable antipsychotic less than 2 injection cycles prior to baseline (so, for example, if the drug is injected every 2 weeks, the patient could not enroll in the study if they had received an injection within the last 4 weeks) Received Electroconvulsive Therapy (ECT) within the last month Began psychotherapy ("talk therapy") within 2 months In the past month was treated with any of these medications: carbamazepine, oxcarbazepine, fluoxetine, paroxetine, or clozapine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
001
002